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FDA Drug Application 020204 by BAYER

Application Number020204
Application Type New Drug Application
Sponsor ApplicantBAYER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/11/1994N12297000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm 7/28/2005
AP08/12/1994SCM       
AP02/10/1995SCP       
AP08/1/1996SCM       
AP04/16/1998SCF       
AP011/20/1998SCP       
AP03/6/2001SLR910007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20204S7LTR.PDF 3/6/2001
AP03/19/2002SLR3454008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20204s8ltr.pdf 3/19/2002
AP08/23/2000SLR       
AP05/11/2000SCM       
AP06/7/2000SCM       
AP01/3/2001SCM       
AP03/27/2001SCM       
AP012/21/2001SCS       
AP08/30/2002SCM3453016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20204scm016ltr.pdf 8/30/2002
AP03/22/2004SLR8017019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20204slr019ltr.pdf 3/24/2004
AP05/4/2005SLR11587021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020204s021ltr.pdf 5/5/2005
AP05/4/2005SLR11588021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020204s021lbl.pdf 5/5/2005
AP01/5/2006SLR13434023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020204s023ltr.pdf 1/20/2006
AP011/24/2008SLR21283031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020204s031ltr.pdf 11/26/2008
AP04/15/2009SLR22294032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020204s032ltr.pdf 4/21/2009
AP011/3/2010SLR26901035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020204s035ltr.pdf 11/8/2010
AP02/18/2011SLR27959036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020204s036ltr.pdf 2/24/2011
AP04/8/2011SLR28518037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020204s037ltr.pdf 4/11/2011
AP02/7/2013SLR35119038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020204Orig1s038ltr.pdf 2/8/2013
AP02/7/2013SLR38268038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020204Orig1s038lbl.pdf 1/14/2014
AP03/15/2012SLR32145039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020204Orig1s039ltr.pdf 3/19/2012
AP03/16/2012SLR32154040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020204s40ltr.pdf 3/19/2012
AP011/13/2012SCM       
AP01/3/2013SCM34850042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020204Orig1s042ltr.pdf 1/7/2013
AP01/7/2013SCM       
AP04/18/2013SLR35764044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020204Orig1s044ltr.pdf 4/23/2013
AP04/18/2013SLR37880044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020204Orig1s044lbl.pdf 11/21/2013
AP02/4/2015SCM       
AP02/25/2016SCM46346048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020204Orig1s048Lbl.pdf 6/17/2016
AP07/28/2016SCM       




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